IVEMEND 115 mg powder for solution for infusion
fosaprepitant dimeglumine
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What IVEMEND is and what it is used for
- 2. Before you use IVEMEND
- 3. How to use IVEMEND
- 4. Possible side effects
- 5. How to store IVEMEND
- 6. Further information
What Ivemend Is And What It Is Used For
IVEMEND is used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment).
Before You Use Ivemend
Do not use IVEMEND
- If you are allergic (hypersensitive) to fosaprepitant (which is converted to aprepitant in your body), aprepitant, or to polysorbate 80 or any of the other ingredients.
- With medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell your doctor if you are taking these medicines since your treatment must be modified before you start using IVEMEND.
Take special care with IVEMEND:
- If you have liver disease
Ivemend is not for use in children and adolescents under 18 years of age.
Using IVEMEND with other medicines
IVEMEND can affect other medicines both during and after treatment with IVEMEND. There are some medicines that should not be taken with IVEMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also Do not use IVEMEND).
IVEMEND should be used with caution with other medicines.
The effects of IVEMEND or other medicines might be influenced if you take IVEMEND together with other medicines including those listed below.
- cyclosporine, tacrolimus, sirolimus, and everolimus (immunosupressants),
- alfentanil, and fentanyl (used to treat pain),
- quinidine (used to treat an irregular heart beat),
- irinotecan (medicine used to treat cancer),
- medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating migraines),
- warfarin (a blood thinner; blood tests may be required),
- birth control medicines (which may not work as well; another or additional form of birth control should be used for up to 2 months after using IVEMEND),
- rifampin, clarithromycin, telithromycin (antibiotics used to treat infections),
- phenytoin (a medicine used to treat seizures),
- carbamazepine (used to treat depression and epilepsy),
- midazolam, triazolam, and phenobarbital (medicines used to produce calmness or help you sleep),
- St. John’s Wort (an herbal preparation used to treat depression),
- protease inhibitors (used to treat HIV infections),
- ketoconazole, itraconazole, voriconazole, and posaconazole (antifungals),
- nefazodone (used to treat depression),
- diltiazem (a medicine used to treat high blood pressure),
- corticosteroids (such as dexamethasone and methylprednisolone),
- anti-anxiety drugs (such as alprazolam), and
- tolbutamide (a medicine used to treat diabetes)
Before starting treatment, it is important that you tell your doctor about any other medicines or herbal remedies you are taking, have recently taken, or plan to take, even those obtained without a prescription.
Pregnancy and breast-feeding
You should not use IVEMEND during pregnancy unless clearly necessary. It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving IVEMEND.
Birth control medicines (these can include birth control pills, skin patches, implants, and certain Intrauterine devices [IUDs] that release hormones) may not work adequately when taken with IVEMEND; another or additional form of contraception should be used during treatment with IVEMEND and for up to 2 months after using IVEMEND.
It is not known whether IVEMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with IVEMEND. It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before receiving IVEMEND.
Driving and using machines
It should be taken into account that some people get dizzy and get sleepy after using IVEMEND. If you get dizzy or get sleepy, you should avoid driving or operating machines after using IVEMEND. (See section 4 POSSIBLE SIDE EFFECTS).
How To Use Ivemend
The recommended dose of IVEMEND is 115 mg fosaprepitant (IVEMEND) on Day 1 only of a 3-day regimen.
The powder is reconstituted and diluted before use. The solution for infusion is given via an intravenous infusion (a drip) 30 minutes before you start your chemotherapy treatment.
On Days 2 and 3 following your chemotherapy treatment you will receive one 80 mg capsule of aprepitant each morning.
Possible Side Effects
Like all medicines, IVEMEND can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in every 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).
Common side effects are:
- burping, constipation, diarrhoea, indigestion,
- dizziness, headache
- weakness, tiredness,
- loss of appetite,
- hiccups
- increased liver blood tests.
Uncommon side effects are:
- abnormal dreaming, difficulty thinking , lack of energy, sleepiness
- acne, oily skin, rash, itching, sensitivity of the skin to sun, sores on the skin, excessive sweating
- anxiousness, euphoria (feeling of extreme happiness), disorientation,
- bacterial infection, fungal infection,
- stomach ulcer, nausea, vomiting, heartburn, taste disturbance, stomach pain, bloating, severe constipation, dry mouth, inflammation of the small intestine and colon, passing wind, sores in mouth,
- presence of red blood cells in the urine, increased painful or burning urination, passing more urine than normal,
- chest discomfort, swelling, generally feeling unwell, chills, change in the manner of walking,
- reddening of the face, hot flush
- cough, mucus in the back of throat, throat irritation, sneezing, sore throat,
- eye discharge and itching,
- ringing in the ear,
- muscle cramp or pain, muscle weakness,
- excessive thirst, weight gain or loss, high sugar levels in the blood,
- slow heartbeat, fast or irregular heart beats, heart and blood vessel disease, blood pressure increased, vein inflammation,
- fever with increased risk of infection, lowering of red blood cells, lowering of white blood cells, low sodium levels in the blood,
- infusion site pain, hardening of site of infusion, infusion-site redness, infusion-site itching.
Single cases of the following have been reported:
- Stevens-Johnson syndrome (rare severe skin reaction),
- angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing) ,
- serious constipation, small bowel not working properly (sub-ileus),
- urticaria (hives).
Since the product has been on the market the following side effects have been reported (frequency not known):
- Allergic reactions, which may be sudden and/or serious, and may include hives, rash, itching, redness of the face/skin and cause difficulty in breathing or swallowing.
If any of the side effects gets serious, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Ivemend
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and vial. The first 2 numbers indicate the month; the next 4 numbers indicate the year.
Store in a refrigerator (2°C - 8°C).
The reconstituted and diluted solution is stable for 24 hours at 25°C.
Medicines should not be disposed of via wastewater or house hold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What IVEMEND contains
- The active substance is fosaprepitant. Each vial contains fosaprepitant dimeglumine equivalent to 115 mg fosaprepitant. After reconstitution 1 ml of solution contains 1 mg fosaprepitant.
- The other ingredients are: disodium edetate (E386), polysorbate 80 (E433), lactose anhydrous, sodium hydroxide (E524) (for pH adjustment) and/or hydrochloric acid diluted (E507) (for pH adjustment).
What IVEMEND looks like and contents of the pack
IVEMEND is a white to off-white powder for solution for infusion.
The powder is contained in a clear glass vial with a rubber stopper and an aluminum seal with a blue plastic flip off cap.
IVEMEND will be available as a pack of 1 vial or 10 vials of 115 mg fosaprepitant.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
medinfo_uk@merck.com
This leaflet was last approved in March 2010
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
PIL.IVE.10.UK.3235.II-007
No comments:
Post a Comment